EMEA-001231-PIP02-13-M09
Key facts
Invented name |
Samsca and associated names
|
Active substance |
Tolvaptan
|
Therapeutic area |
|
Decision number |
P/0157/2022
|
PIP number |
EMEA-001231-PIP02-13-M09
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Otsuka Pharmaceutical Netherlands B.V.
E-mail: paediatric-info@otsuka-europe.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|